Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Why Is Biopharma Left Out Of The U.S. Infrastructure Conversation?

Investment manager BlackRock gathered powerful investors to discuss along with government officials the nation’s physical and economic backbone. The Infrastructure Summit clarified the biopharma industry including CDMOs are in a battle for investments and infrastructure. Analysis from Chief Editor Louis Garguilo.

GUEST COLUMNISTS

Why Contamination Control By Design Should Matter To Your CDMO
EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.
Closing The MES Value Gap: Why Technology Isn't The Problem
Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.
Why Isolators Do Not Automatically Ensure Annex 1 Compliance
Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is not the technology itself, but how it is applied.
Why Are Life Science Companies So Poorly Prepared For RIM's Future?
Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.
CDMO Capacity Crunch: Are Biotechs Wasting Time On The Wrong CDMO?
Biotechs often default to one of two flawed instincts: pursue the biggest name in the space or go with the lowest bidder. To avoid misalignment, look at these less visible factors.
April 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Tackling The Cell & Gene Therapy Sector's Practical Post-Approval Problem
As the regulatory landscape continues to evolve, cell and gene therapy companies must plan post-approval change programs with regulatory monitoring built in from the start.
Why Your MES RFP Is Failing Before It Starts
Many manufacturing execution system requests for proposals fail. Not because vendors cannot deliver or the tech is immature, but because the requirements are written backward.

PHARMA OUTSOURCING WHITE PAPERS

Project Management: Sphere Of Influence
The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.

Phase-Appropriate Approaches To Manufacturing And Testing
Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.
Process Analytical Technology In The ADC Bioconjugation Process
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
Continuous Manufacturing For API Breakthroughs
Observe how a compound library, designed for chemical diversity and lead-like properties, uses advanced filtering to improve hit discovery, speed hit-to-lead development, and boost early-stage small molecule drug discovery.
Circular Single-Stranded Cell-Free DNA For Next-Gen Gene Editing
Next‑gen circular DNA payloads enhance gene insertion by improving stability, lowering cytotoxicity, and enabling precise, scalable integration across HDR, recombination, and transposition systems.
Next Generation Sequencing In Viral Safety Testing
Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.